Operation system for main researchers of clinical trials

Abstract

The invention discloses an operation system for main researchers of clinical trials, which relates to the technical field of clinical trials and comprises a patient management end, a task management and reminding end, a visit plan and arrangement end, a data collection and recording end, a report generation and analysis end, an adverse event report end, a treatment management end and a communication and cooperation end. The patient management end, the task management and reminding end, the visit planning and arrangement end, the data collection and recording end, the report generation and analysis end, the adverse event report end, the treatment management end and the communication and cooperation end are in data communication through a private network and a private line network. The method has the effects of helping main researchers to effectively manage the test work and improving the quality and reliability of the test.

Description

Technical Field

[0001] This application relates to the field of clinical trial technology, and in particular to an operating system for a principal investigator in a clinical trial. Background Technology

[0002] The Principal Investigator Operating System (PIS) is a system designed to support and manage the work and tasks of the Principal Investigator (PIA) during the execution of a clinical trial. The PIA is a key role responsible for supervising, directing, and executing the clinical trial; they are responsible for the overall design of the trial, the execution of the protocol, data collection, and analysis.

[0003] However, the principal investigators have a lot of work to do, making it difficult to centrally manage their work. They are unable to effectively manage the experimental work, including overall design, execution, data collection and analysis, which requires improvement. Summary of the Invention

[0004] To help principal investigators effectively manage trial work and improve the quality and reliability of trials, this application provides an operating system for principal investigators in clinical trials.

[0005] This application provides a working system for principal investigators in clinical trials, employing the following technical solution:

[0006] A clinical trial principal investigator's operating system includes a patient management terminal, comprising modules for patient registration and screening, patient enrollment and exit management, follow-up planning and scheduling, patient status tracking, data collection and recording, data query and reporting, and patient safety and privacy protection.

[0007] The task management and reminder module includes modules for task creation and assignment, task priority and due date, task status tracking, reminders and notifications, task history, and cross-team collaboration.

[0008] The visit planning and scheduling module includes a visit planning module, a visit scheduling and reminder module, a visit status tracking module, a visit document management module, and a visit history module.

[0009] The data collection and recording module includes a data collection form design module, a data input and validation module, an automatic data collection module, a data auditing and cleaning module, a data recording and storage module, a data query and export module, and a data security and privacy protection module.

[0010] The report generation and analysis module includes a report template and customization module, a data aggregation and statistical analysis module, a data visualization module, a data interaction and export module, a statistical report generation module, and a real-time data update module.

[0011] The adverse event reporting module includes an adverse event recording module, an adverse event classification and grading module, an adverse event assessment module, an adverse event report generation module, an adverse event notification and reporting module, and an adverse event tracking and handling module.

[0012] The treatment management module includes modules for treatment planning and protocols, treatment allocation and randomization, drug management and storage, treatment execution and monitoring, adverse event and side effect management, and treatment effectiveness evaluation.

[0013] The communication and collaboration module includes internal messaging and notification modules, task assignment and tracking modules, collaboration tools and document sharing modules, meeting and scheduling modules, external collaboration and communication modules, and real-time data sharing and tracking modules.

[0014] Preferably, the patient management terminal, task management and reminder terminal, visit planning and scheduling terminal, data collection and recording terminal, report generation and analysis terminal, adverse event reporting terminal, treatment management terminal, and communication and collaboration terminal communicate with each other via a dedicated network.

[0015] Preferably, the patient registration and screening module includes a patient registration and screening unit and a patient registration and screening database unit. The patient registration and screening unit is used by the principal investigator to record the basic information of patients, and the principal investigator can screen patients and make enrollment decisions according to preset screening criteria. The patient registration and screening database unit is used to store patient registration and screening information.

[0016] The patient enrollment and exit management module includes a patient enrollment and exit management unit and a patient enrollment and exit management database unit. The patient enrollment and exit management unit is used to track the patient enrollment process and record the enrollment time, enrollment conditions, and related documents. The patient enrollment and exit management database unit is used to store patient enrollment and exit management information.

[0017] The follow-up planning and scheduling module includes a follow-up planning and scheduling unit and a follow-up planning and scheduling database unit. The follow-up planning and scheduling unit is used to develop and manage the patient's follow-up plan, with the principal investigator arranging the patient's follow-up time and content, and recording the follow-up results and necessary data. The follow-up planning and scheduling database unit is used to store follow-up planning and scheduling information.

[0018] The patient status tracking module includes a patient status tracking unit and a patient status tracking database unit. The patient status tracking unit is used to track changes in the patient's status during the trial, including treatment progress, occurrence and management of adverse events, and dose adjustments. The patient status tracking database unit is used to store patient status tracking information.

[0019] The data collection and recording module includes a data collection and recording unit and a data collection and recording database unit. The data collection and recording unit is used for collecting and recording patient data, where the principal investigator inputs or verifies the accuracy of the patient data, including diagnostic results, laboratory tests, drug use and dosage, and treatment response. The data collection and recording database unit is used to store data collection and recording information.

[0020] The data query and reporting module includes a data query and reporting unit and a data query and reporting database unit. The data query and reporting unit is used for querying and reporting patient data, and generates reports and statistical information on patient data based on specific screening conditions and variables. The data query and reporting database unit is used to store data query and reporting information.

[0021] The patient safety and privacy protection module includes a patient safety and privacy protection unit and a patient safety and privacy protection database unit. The patient safety and privacy protection unit is used to establish a security and privacy protection mechanism for patient data to ensure the confidentiality and compliance of patient information. The patient safety and privacy protection database unit is used to store patient safety and privacy protection information.

[0022] Preferably, the task creation and assignment module includes a task creation and assignment unit and a task creation and assignment database unit. The task creation and assignment unit is used by the principal investigator to create new tasks and assign them to relevant research team members. The tasks can be various trial-related tasks such as those targeting specific patients, data collection, report generation, and meeting arrangements. The task creation and assignment database unit is used to store task creation and assignment information.

[0023] The task priority and deadline module includes a task priority and deadline unit and a task priority and deadline database unit. The task priority and deadline unit is used by the principal investigator to set the priority and deadline of the task, and provides a task list and reminder function to help the principal investigator understand the current task status and follow up in a timely manner. The task priority and deadline database unit is used to store task priority and deadline information.

[0024] The task status tracking module includes a task status tracking unit and a task status tracking database unit. The task status tracking unit is used by the principal researcher to track the status and progress of the task. The principal researcher can mark the task as completed, in progress, or pending, and record corresponding notes and updates. The task status tracking database unit is used to store task status tracking information.

[0025] The reminder and notification module includes a reminder and notification unit and a reminder and notification database unit. The reminder and notification unit is used to send reminders and notifications to relevant research team members through internal messaging functions, emails, or mobile application push notifications. The reminder and notification database unit is used to store reminder and notification information.

[0026] The task history module includes a task history unit and a task history database unit. The task history unit is used to record the historical history of tasks, including information such as task creation time, assigned personnel, and status changes, to help principal researchers trace the execution status and follow-up process of tasks. The task history database unit is used to store task history information.

[0027] The cross-team collaboration module includes a cross-team collaboration unit and a cross-team collaboration database unit. The cross-team collaboration unit is used for the principal researcher to share tasks, discuss problems, and jointly solve difficult problems with other research team members. The cross-team collaboration database unit is used to store cross-team collaboration information.

[0028] Preferably, the visit planning module includes a visit planning unit and a visit planning database unit. The visit planning unit is used to develop a visit plan, determine the time points for patient visits and follow-ups, and develop the visit plan according to the specific requirements and procedures of the trial, and adjust it according to the research agreement and regulatory requirements. The visit planning database unit is used to store visit planning information.

[0029] The visit scheduling and reminder module includes a visit scheduling and reminder unit and a visit scheduling and reminder database unit. The visit scheduling and reminder unit allows the principal investigator to send planned visit schedules to patients and set reminder notifications to ensure that patients and the research team are informed of the visit time and location in a timely manner, which is achieved through the system's internal messaging function, email, or mobile application push notifications. The visit scheduling and reminder database unit is used to store visit scheduling and reminder information.

[0030] The visit status tracking module includes a visit status tracking unit and a visit status tracking database unit. The visit status tracking unit is used to track and record the status and progress of each patient visit. The principal investigator can mark the visit as completed, in progress, or pending, and record the relevant visit results and data. The visit status tracking database unit is used to store visit status tracking information.

[0031] The visit document management module includes a visit document management unit and a visit document management database unit. The visit document management unit allows principal investigators and research teams to upload, manage, and share visit-related documents and materials. The visit document management database unit stores visit document management information.

[0032] The visit history module includes a visit history unit and a visit history database unit. The visit history unit is used to record the visit history of each patient, including visit time, visit purpose, and visit results. The visit history database unit is used to store the visit history information.

[0033] Preferably, the data collection form design module includes a data collection form design unit and a data collection form design database unit. The data collection form design unit is used by the principal investigator to design and create data collection forms, wherein the forms can be defined according to the specific needs of the experiment and the research protocol, and contain various data fields and variables that need to be collected; the data collection form design database unit is used to store data collection form design information.

[0034] The data input and verification module includes a data input and verification unit and a data input and verification database unit. The data input and verification unit provides a data input interface, allowing the principal investigator to manually input patient data and verify it to ensure that the input data conforms to the prescribed format and range, and to provide error prompts or warning messages. The data input and verification database unit stores data input and verification information.

[0035] The automatic data collection module includes an automatic data collection unit and an automatic data collection database unit. The automatic data collection unit is used to integrate with other test-related systems or equipment to automatically collect test data. The automatic data collection database unit is used to store automatic data collection information.

[0036] The data review and cleaning module includes a data review and cleaning unit and a data review and cleaning database unit. The data review and cleaning unit is used to allow the principal investigator to review and clean the data and perform necessary corrections and cleaning operations. The data review and cleaning database unit is used to store data review and cleaning information.

[0037] The data recording and storage module includes a data recording and storage unit and a data recording and storage database unit. The data recording and storage unit is used to automatically record and store the collected data. The data records include timestamps, data sources, and operator information to ensure the traceability and reliability of the data. The data recording and storage database unit is used to store data records and storage information.

[0038] The data query and export module includes a data query and export unit and a data query and export database unit. The data query and export unit provides data query and export functions, allowing researchers to query and retrieve specific data as needed and export it in various formats for further analysis and reporting. The data query and export database unit stores data query and export information.

[0039] The data security and privacy protection module includes a data security and privacy protection unit and a data security and privacy protection database unit. The data security and privacy protection unit is used to establish a data security and privacy protection mechanism to ensure the confidentiality and compliance of patient data, and only authorized research team members can access and process patient data. The data security and privacy protection database unit is used to store data security and privacy protection information.

[0040] Preferably, the report template and customization module includes a report template and customization unit and a report template and customization database unit. The report template and customization unit is used to provide a variety of report templates for the principal investigator to choose from and allows customization according to the experimental needs. The principal investigator can select the content, format and style of the report as needed, and add custom charts, tables and text. The report template and customization database unit is used to store report templates and customization information.

[0041] The data aggregation and statistical analysis module includes a data aggregation and statistical analysis unit and a data aggregation and statistical analysis database unit. The data aggregation and statistical analysis unit is used to provide data aggregation and statistical analysis functions, perform statistical description of experimental data, calculate indicators, and generate summary reports. The data aggregation and statistical analysis database unit is used to store data aggregation and statistical analysis information.

[0042] The data visualization module includes a data visualization unit and a data visualization database unit. The data visualization unit is used to allow the principal researcher to present experimental results through data visualization. The data visualization database unit is used to store data visualization information.

[0043] The data interaction and export module includes a data interaction and export unit and a data interaction and export database unit. The data interaction and export unit is used to provide data interaction and export functions, allowing the principal researcher to share data and reports with other research team members and export reports in multiple formats. The data interaction and export database unit is used to store data interaction and export information.

[0044] The statistical report generation module includes a statistical report generation unit and a statistical report generation database unit. The statistical report generation unit is used to generate statistical reports on experimental results, wherein the statistical report includes detailed results of data analysis, statistical hypothesis testing, confidence intervals, effect sizes, and other information to support the interpretation and discussion of research results. The statistical report generation database unit is used to store statistical report generation information.

[0045] The real-time data update module includes a real-time data update unit and a real-time data update database unit. The real-time data update unit is used by the principal investigator to update and regenerate reports at any time. When experimental data changes, the system can automatically update the relevant reports and provide the latest analysis results. The real-time data update database unit is used to store real-time data update information.

[0046] Preferably, the adverse event recording module includes an adverse event recording unit and an adverse event recording database unit, which allows the principal investigator to record adverse events occurring in each patient; the adverse event recording database unit is used to store adverse event recording information.

[0047] The adverse event classification and grading module includes an adverse event classification and grading unit and an adverse event classification and grading database unit. The adverse event classification and grading unit is used to provide the function of classifying and grading adverse events, mainly by researchers classifying and grading events according to their nature, severity, and related factors. The adverse event classification and grading database unit is used to store adverse event classification and grading information.

[0048] The adverse event assessment module includes an adverse event assessment unit and an adverse event assessment database unit. The adverse event assessment unit contains adverse event assessment tools, which are used by the principal investigator to assess events and determine their association with the trial intervention and possible causes. The adverse event assessment database unit is used to store adverse event assessment information.

[0049] The adverse event report generation module includes an adverse event report generation unit and an adverse event report generation database unit. The adverse event report generation unit allows principal investigators to generate adverse event reports. The reports may include summaries, statistical information, and relevant data of all adverse events, as well as necessary analysis and interpretation, and the reports are formatted in accordance with regulatory requirements and research protocols. The adverse event report generation database unit is used to store adverse event report generation information.

[0050] The adverse event notification and reporting module includes an adverse event notification and reporting unit and an adverse event notification and reporting database unit. The adverse event notification and reporting unit is used to provide the function of adverse event notification and reporting, allowing the principal investigator to notify relevant research team members, regulatory agencies, and ethics committees of adverse events. The adverse event notification and reporting database unit is used to store adverse event notification and reporting information.

[0051] The adverse event tracking and handling module includes an adverse event tracking and handling unit and an adverse event tracking and handling database unit. The adverse event tracking and handling unit is used to track and record the handling process of each adverse event, including corrective measures taken, follow-up status, and results. The adverse event tracking and handling database unit is used to store adverse event tracking and handling information.

[0052] Preferably, the treatment plan and protocol module includes a treatment plan and protocol unit and a treatment plan and protocol database unit, wherein the treatment plan and protocol unit is used to allow the principal investigator to create and manage the treatment plan and protocol for the trial; and the treatment plan and protocol database unit is used to store treatment plan and protocol information.

[0053] The treatment allocation and randomization module includes a treatment allocation and randomization unit and a treatment allocation and randomization database unit. The treatment allocation and randomization unit is used to support the treatment allocation and randomization function to ensure that patients are randomly assigned to appropriate treatment groups, automatically allocate patients to treatment groups, and / or provide randomization tools for the principal investigator to perform manual allocation. The treatment allocation and randomization database unit is used to store treatment allocation and randomization information.

[0054] The drug management and storage module includes a drug management and storage unit and a drug management and storage database unit. The drug management and storage unit is used to allow the principal investigator to manage drugs and therapeutic items involved in the trial; the drug management and storage database unit is used to store drug management and storage information.

[0055] The treatment execution and monitoring module includes a treatment execution and monitoring unit and a treatment execution and monitoring database unit. The treatment execution and monitoring unit is used to record and monitor the patient's treatment status. The principal investigator can record information such as treatment implementation, treatment compliance, and dosage adjustments, and perform necessary monitoring and tracking. The treatment execution and monitoring database unit is used to store treatment execution and monitoring information.

[0056] The adverse event and side effect management module includes an adverse event and side effect management unit and an adverse event and side effect management database unit. The adverse event and side effect management unit allows the principal investigator to record and manage treatment-related adverse events and side effects, and the principal investigator can track patient treatment responses and adverse events, and take appropriate measures to handle and report them. The adverse event and side effect management database unit is used to store adverse event and side effect management information.

[0057] The treatment efficacy evaluation module includes a treatment efficacy evaluation unit and a treatment efficacy evaluation database unit. The treatment efficacy evaluation unit is used to provide treatment efficacy evaluation tools and indicators to help principal investigators evaluate the effectiveness and efficacy of treatment. The treatment efficacy evaluation database unit is used to store treatment efficacy evaluation information.

[0058] Preferably, the internal message and notification module includes an internal message and notification unit and an internal message and notification database unit. The internal message and notification unit is used to provide internal message and notification functions, allowing the principal researcher to directly communicate and share information with members of the experimental team. The internal message and notification database unit is used to store internal message and notification information.

[0059] The task allocation and tracking module includes a task allocation and tracking unit and a task allocation and tracking database unit. The task allocation and tracking unit is used to allow the principal investigator to allocate tasks to members of the experimental team and track the execution status and progress of the tasks. The task allocation and tracking database unit is used to store task allocation and tracking information.

[0060] The collaboration tools and document sharing module includes a collaboration tools and document sharing unit and a collaboration tools and document sharing database unit. The collaboration tools and document sharing unit integrates collaboration tools to enable principal researchers and collaborators to jointly edit and share experiment-related documents, research plans, and reports. The collaboration tools and document sharing database unit is used to store collaboration tools and document sharing information.

[0061] The meeting and scheduling module includes a meeting and scheduling unit and a meeting and scheduling database unit. The meeting and scheduling unit is used to support meeting and scheduling functions, allowing principal researchers to create and manage meetings, invite participants, and share meeting agendas and related documents. The meeting and scheduling database unit is used to store meeting and scheduling information.

[0062] The external collaboration and communication module includes an external collaboration and communication unit and an external collaboration and communication database unit. The external collaboration and communication unit is used to support collaboration and communication with external partners, regulatory agencies, ethics committees, and other relevant parties. The external collaboration and communication database unit is used to store external collaboration and communication information.

[0063] The real-time data sharing and tracking module includes a real-time data sharing and tracking unit and a real-time data sharing and tracking database unit. The real-time data sharing and tracking unit is used to allow principal investigators to share experimental data and results in real time for discussion and feedback with team members. The real-time data sharing and tracking database unit is used to store real-time data sharing and tracking information.

[0064] In summary, this application includes at least one of the following beneficial technical effects: This system, through patient management, task management and reminder, visit planning and scheduling, data collection and recording, report generation and analysis, adverse event reporting, treatment management, and communication and collaboration, establishes a centralized and coordinated platform, improving the work efficiency of principal investigators and the quality of trial management. It helps principal investigators to effectively manage trial work, improve the quality and reliability of trials, strengthen teamwork and communication, and ultimately achieve the successful conduct and smooth completion of clinical trials. Attached Figure Description

[0065] Figure 1 This is a schematic block diagram illustrating the operating system of the principal investigator in a clinical trial, as described in the embodiments of this application.

[0066] Figure 2 This is a schematic block diagram illustrating the main aspects of the patient management terminal in this application embodiment.

[0067] Figure 3 This is a schematic block diagram illustrating the main features of the task management and reminder terminal in this application embodiment.

[0068] Figure 4 This is a schematic block diagram illustrating the visit planning and scheduling aspects of the embodiments of this application.

[0069] Figure 5 This is a schematic block diagram illustrating the main data collection and recording end in the embodiments of this application.

[0070] Figure 6 This is a schematic block diagram illustrating the report generation and analysis terminals, which are the main features of this application's embodiments.

[0071] Figure 7 This is a schematic block diagram illustrating the adverse event reporting terminal in the embodiments of this application.

[0072] Figure 8 This is a schematic block diagram illustrating the main treatment management terminal in the embodiments of this application.

[0073] Figure 9 This is a schematic block diagram illustrating the main communication and collaboration terminals in the embodiments of this application.

[0074] Figure labeling: 1. Patient Management Terminal; 101. Patient Registration and Screening Module; 101a. Patient Registration and Screening Unit; 101b. Patient Registration and Screening Database Unit; 102. Patient Enrollment and Exit Management Module; 102a. Patient Enrollment and Exit Management Unit; 102b. Patient Enrollment and Exit Management Database Unit; 103. Follow-up Planning and Scheduling Module; 103a. Follow-up Planning and Scheduling Unit; 103b. Follow-up Planning and Scheduling Database Unit; 104. Patient Status Tracking Module; 104a. Patient Status Tracking Unit; 104b. Patient Status Tracking Database Unit; 105. Data Collection and Recording Module; 105a. Data Collection and Recording Unit; 105b. Data Collection and Recording Module Database Unit; 106. Data Query and Reporting Module; 106a. Data Query and Reporting Unit; 106b. Data Query and Reporting Database Unit; 107. Patient Safety and Privacy Protection Module; 107a. Patient Safety and Privacy Protection Unit; 107b. Patient Safety and Privacy Protection Database Unit; 2. Task Management and Reminder Terminal; 201. Task Creation and Assignment Module; 201a. Task Creation and Assignment Unit; 201b. Task Creation and Assignment Database Unit; 202. Task Priority and Deadline Module; 202a. Task Priority and Deadline Unit; 202b. Task Priority and Deadline Database Unit; 203. Task Status Tracking Module; 203a. Task Status Tracking Unit; 20 3b. Task Status Tracking Database Unit; 204. Reminder and Notification Module; 204a. Reminder and Notification Unit; 204b. Reminder and Notification Database Unit; 205. Task History Module; 205a. Task History Unit; 205b. Task History Database Unit; 206. Cross-Team Collaboration Module; 206a. Cross-Team Collaboration Unit; 206b. Cross-Team Collaboration Database Unit; 3. Visit Planning and Scheduling Terminal; 301. Visit Planning Module; 301a. Visit Planning Unit; 301b. Visit Planning Database Unit; 302. Visit Scheduling and Reminder Module; 302a. Visit Scheduling and Reminder Unit; 302b. Visit Scheduling and Reminder Database Unit; 303. Visit 303a Visit Status Tracking Module; 303b Visit Status Tracking Database Unit; 304 Visit Document Management Module; 304a Visit Document Management Unit; 304b Visit Document Management Database Unit; 305 Visit History Record Module; 305a Visit History Record Unit; 305b Visit History Record Database Unit; 4. Data Collection and Recording Terminal; 401 Data Collection Form Design Module; 401a Data Collection Form Design Unit; 401b Data Collection Form Design Database Unit; 402 Data Input and Validation Module; 402a Data Input and Validation Unit; 402b Data Input and Validation Database Unit; 403 Automatic Data Collection Module;403a. Automatic Data Collection Unit; 403b. Automatic Data Collection Database Unit; 404. Data Review and Cleaning Module; 404a. Data Review and Cleaning Unit; 404b. Data Review and Cleaning Database Unit; 405. Data Recording and Storage Module; 405a. Data Recording and Storage Unit; 405b. Data Recording and Storage Database Unit; 406. Data Query and Export Module; 406a. Data Query and Export Unit; 406b. Data Query and Export Database Unit; 407. Data Security and Privacy Protection Module; 407a. Data Security and Privacy Protection Unit; 407b. Data Security and Privacy Protection Database Unit; 5. Report Generation and Analysis Terminal; 501. Report Template and Customization Module; 501a. Report Templates and Customization Unit; 501b. Report Templates and Customization Database Unit; 502. Data Summary and Statistical Analysis Module; 502a. Data Summary and Statistical Analysis Unit; 502b. Data Summary and Statistical Analysis Database Unit; 503. Data Visualization Module; 503a. Data Visualization Unit; 503b. Data Visualization Database Unit; 504. Data Interaction and Export Module; 504a. Data Interaction and Export Unit; 504b. Data Interaction and Export Database Unit; 505. Statistical Report Generation Module; 505a. Statistical Report Generation Unit; 505b. Statistical Report Generation Database Unit; 506. Real-time Data Update Module; 506a. Real-time Data Update Unit; 506b. 6. Real-time data update database unit; 6. Adverse event reporting terminal; 601. Adverse event recording module; 601a. ​​Adverse event recording unit; 601b. Adverse event recording database unit; 602. Adverse event classification and grading module; 602a. Adverse event classification and grading unit; 602b. Adverse event classification and grading database unit; 603. Adverse event assessment module; 603a. Adverse event assessment unit; 603b. Adverse event assessment database unit; 604. Adverse event report generation module; 604a. Adverse event report generation unit; 604b. Adverse event report generation database unit; 605. Adverse event notification and reporting module; 605a. Adverse event notification and reporting unit; 605b 606. Adverse Event Notification and Reporting Database Unit; 606. Adverse Event Tracking and Handling Module; 606a. Adverse Event Tracking and Handling Unit; 606b. Adverse Event Tracking and Handling Database Unit; 7. Treatment Management Terminal; 701. Treatment Plan and Protocol Module; 701a. Treatment Plan and Protocol Unit; 701b. Treatment Plan and Protocol Database Unit; 702. Treatment Allocation and Randomization Module; 702a. Treatment Allocation and Randomization Unit; 702b. Treatment Allocation and Randomization Database Unit; 703. Drug Management and Storage Module; 703a. Drug Management and Storage Unit; 703b. Drug Management and Storage Database Unit; 704. Treatment Execution and Monitoring Module; 704a. Treatment Execution and Monitoring Unit;704b. Treatment execution and monitoring database unit; 705. Adverse event and side effect management module; 705a. Adverse event and side effect management unit; 705b. Adverse event and side effect management database unit; 706. Treatment efficacy evaluation module; 706a. Treatment efficacy evaluation unit; 706b. Treatment efficacy evaluation database unit; 8. Communication and collaboration terminal; 801. Internal message and notification module; 801a. Internal message and notification unit; 801b. Internal message and notification database unit; 802. Task assignment and tracking module; 802a. Task assignment and tracking unit; 802b. Task 803. Database Unit for Allocation and Tracking; 803a. Collaboration Tools and Document Sharing Unit; 803b. Collaboration Tools and Document Sharing Database Unit; 804. Meeting and Scheduling Module; 804a. Meeting and Scheduling Unit; 804b. Meeting and Scheduling Database Unit; 805. External Collaboration and Communication Module; 805a. External Collaboration and Communication Unit; 805b. External Collaboration and Communication Database Unit; 806. Real-Time Data Sharing and Tracking Module; 806a. Real-Time Data Sharing and Tracking Unit; 806b. Real-Time Data Sharing and Tracking Database Unit. Detailed Implementation

[0075] The following is in conjunction with the appendix Figure 1-9 This application will be described in further detail.

[0076] This application discloses an operating system for principal investigators in clinical trials.

[0077] Reference Figure 1 A clinical trial principal investigator's operating system includes a patient management terminal 1, a task management and reminder terminal 2, a visit planning and scheduling terminal 3, a data collection and recording terminal 4, a report generation and analysis terminal 5, an adverse event reporting terminal 6, a treatment management terminal 7, and a communication and collaboration terminal 8. The patient management terminal 1, task management and reminder terminal 2, visit planning and scheduling terminal 3, data collection and recording terminal 4, report generation and analysis terminal 5, adverse event reporting terminal 6, treatment management terminal 7, and communication and collaboration terminal 8 communicate with each other via a dedicated network.

[0078] Reference Figure 2 The patient management terminal 1 includes a patient registration and screening module 101, a patient enrollment and exit management module 102, a follow-up plan and arrangement module 103, a patient status tracking module 104, a data collection and recording module 105, a data query and reporting module 106, and a patient safety and privacy protection module 107.

[0079] Specifically, the patient registration and screening module 101 includes a patient registration and screening unit and a patient registration and screening database unit 101b. The patient registration and screening unit is used by the principal investigator to record basic patient information, such as name, age, gender, and contact information. The principal investigator can screen patients and determine their inclusion based on preset screening criteria. The patient registration and screening database unit 101b is used to store patient registration and screening information.

[0080] The patient enrollment and exit management module 102 includes a patient enrollment and exit management unit 102a and a patient enrollment and exit management database unit 102b. The patient enrollment and exit management unit 102a tracks the patient enrollment process, records the enrollment time, enrollment criteria, and related documents, and can also record the reason and date of patient withdrawal from the trial. The patient enrollment and exit management database unit 102b stores patient enrollment and exit management information.

[0081] The follow-up planning and scheduling module 103 includes a follow-up planning and scheduling unit 103a and a follow-up planning and scheduling database unit 103b. The follow-up planning and scheduling unit 103a is used to develop and manage the patient's follow-up plan. The principal investigator schedules the patient's follow-up time and content, and records the follow-up results and necessary data. The follow-up planning and scheduling database unit 103b is used to store follow-up planning and scheduling information.

[0082] The patient status tracking module 104 includes a patient status tracking unit 104a and a patient status tracking database unit 104b. The patient status tracking unit 104a is used to track changes in the patient's status during the trial, including treatment progress, occurrence and management of adverse events, and dose adjustments, which helps to understand the patient's condition and take necessary measures in a timely manner. The patient status tracking database unit 104b is used to store patient status tracking information.

[0083] The data collection and recording module 105 includes a data collection and recording unit 105a and a data collection and recording database unit 105b. The data collection and recording unit 105a is used for collecting and recording patient data, where the principal investigator inputs or verifies the accuracy of patient data, including diagnostic results, laboratory tests, medication use and dosage, and treatment response. The data collection and recording database unit 105b is used to store the data collection and recording information.

[0084] The data query and reporting module 106 includes a data query and reporting unit 106a and a data query and reporting database unit 106b. The data query and reporting unit 106a is used for querying and reporting patient data, enabling principal investigators to find and analyze patient data and generate reports and statistical information based on specific screening criteria and variables. The data query and reporting database unit 106b is used to store data query and reporting information.

[0085] The patient safety and privacy protection module 107 includes a patient safety and privacy protection unit 107a and a patient safety and privacy protection database unit 107b. The patient safety and privacy protection unit 107a is used to establish a security and privacy protection mechanism for patient data, ensuring the confidentiality and compliance of patient information, and ensuring that only authorized research team members can access and process patient data. The patient safety and privacy protection database unit 107b is used to store patient safety and privacy protection information.

[0086] Reference Figure 3 The task management and reminder terminal 2 includes a task creation and assignment module 201, a task priority and deadline module 202, a task status tracking module 203, a reminder and notification module 204, a task history module 205, and a cross-team collaboration module 206.

[0087] Specifically, the task creation and assignment module 201 includes a task creation and assignment unit 201a and a task creation and assignment database unit 201b. The task creation and assignment unit 201a is used by the principal investigator to create new tasks and assign them to relevant research team members. These tasks can be various trial-related tasks, such as those targeting specific patients, data collection, report generation, and meeting scheduling. The task creation and assignment database unit 201b is used to store task creation and assignment information.

[0088] The task priority and deadline module 202 includes a task priority and deadline unit 202a and a task priority and deadline database unit 202b. The task priority and deadline unit 202a is used by the principal investigator to set task priorities and deadlines to ensure timely completion. It also provides a task list and reminder functions to help the principal investigator understand the current task status and follow up promptly. The task priority and deadline database unit 202b is used to store task priority and deadline information.

[0089] The task status tracking module 203 includes a task status tracking unit 203a and a task status tracking database unit 203b. The task status tracking unit 203a is used by the principal investigator to track the status and progress of the task. The principal investigator can mark the task as completed, in progress, or pending, and record corresponding notes and updates. The task status tracking database unit 203b is used to store task status tracking information.

[0090] The reminder and notification module 204 includes a reminder and notification unit 204a and a reminder and notification database unit 204b. The reminder and notification unit 204a is used to send reminders and notifications to relevant research team members to ensure timely task completion. This is achieved through internal messaging functions, email, or mobile application push notifications. The reminder and notification database unit 204b is used to store reminder and notification information.

[0091] The task history module 205 includes a task history unit 205a and a task history database unit 205b. The task history unit 205a records the historical history of tasks, including task creation time, assigned personnel, status changes, and other information to help principal researchers trace the execution and progress of tasks. The task history database unit 205b stores the task history information.

[0092] The cross-team collaboration module 206 includes a cross-team collaboration unit 206a and a cross-team collaboration database unit 206b. The cross-team collaboration unit 206a is used by the principal investigator and other research team members to share tasks, discuss problems, and jointly solve difficulties. The cross-team collaboration database unit 206b is used to store cross-team collaboration information.

[0093] Reference Figure 4 The visit planning and scheduling module 3 includes a visit planning module 301, a visit scheduling and reminder module 302, a visit status tracking module 303, a visit document management module 304, and a visit history module 305.

[0094] Specifically, the visit planning module 301 includes a visit planning unit 301a and a visit planning database unit 301b. The visit planning unit 301a is used to develop visit plans, determine the time points for patient visits and follow-ups, and develop visit plans according to the specific requirements and procedures of the trial, and adjust them according to the research agreement and regulatory requirements. The visit planning database unit 301b is used to store visit planning information.

[0095] The visit scheduling and reminder module 302 includes a visit scheduling and reminder unit 302a and a visit scheduling and reminder database unit 302b. The visit scheduling and reminder unit 302a allows the principal investigator to send planned visit schedules to patients and set reminder notifications to ensure that both patients and the research team are promptly informed of the visit time and location, via internal system messaging, email, or mobile application push notifications. The visit scheduling and reminder database unit 302b stores visit scheduling and reminder information.

[0096] The visit status tracking module 303 includes a visit status tracking unit 303a and a visit status tracking database unit 303b. The visit status tracking unit 303a is used to track and record the status and progress of each patient visit. The principal investigator can mark the visit as completed, in progress, or pending, and record the relevant visit results and data. The visit status tracking database unit 303b is used to store visit status tracking information.

[0097] The visit document management module 304 includes a visit document management unit 304a and a visit document management database unit 304b. The visit document management unit 304a allows principal investigators and research teams to upload, manage, and share visit-related documents and materials, such as visit guidelines, questionnaires, and data collection forms. The visit document management database unit 304b stores visit document management information.

[0098] The visit history module 305 includes a visit history unit 305a and a visit history database unit 305b. The visit history unit 305a records the visit history for each patient, including the visit time, purpose, and results, which helps the principal investigator to trace the patient's visit history and understand the overall progress of the visit. The visit history database unit 305b stores the visit history information.

[0099] Reference Figure 5 The data collection and recording terminal 4 includes a data collection form design module 401, a data input and verification module 402, an automatic data collection module 403, a data audit and cleaning module 404, a data recording and storage module 405, a data query and export module 406, and a data security and privacy protection module 407.

[0100] Specifically, the data collection form design module 401 includes a data collection form design unit 401a and a data collection form design database unit 401b. The data collection form design unit 401a is used by the principal investigator to design and create data collection forms, which can be defined according to the specific needs of the experiment and the research protocol, and include various data fields and variables that need to be collected. The data collection form design database unit 401b is used to store data collection form design information.

[0101] The data input and verification module 402 includes a data input and verification unit 402a and a data input and verification database unit 402b. The data input and verification unit 402a provides a data input interface, allowing the principal investigator to manually input patient data and verify it to ensure the input data conforms to the prescribed format and range, and providing error prompts or warnings. The data input and verification database unit 402b stores data input and verification information.

[0102] The automatic data collection module 403 includes an automatic data collection unit 403a and an automatic data collection database unit 403b. The automatic data collection unit 403a is used to integrate with other test-related systems or equipment to automatically collect test data, such as laboratory test results and instrument measurement data, thereby reducing the workload of manual input and improving data accuracy. The automatic data collection database unit 403b is used to store automatic data collection information.

[0103] The data review and cleaning module 404 includes a data review and cleaning unit 404a and a data review and cleaning database unit 404b. The data review and cleaning unit 404a allows the principal investigator to review and clean the data and perform necessary corrections and cleaning operations. The principal investigator can check the integrity, consistency, and accuracy of the data. The data review and cleaning database unit 404b stores data review and cleaning information.

[0104] The data recording and storage module 405 includes a data recording and storage unit 405a and a data recording and storage database unit 405b. The data recording and storage unit 405a is used to automatically record and store collected data. Data records include timestamps, data sources, and operator information to ensure data traceability and reliability. The data recording and storage database unit 405b is used to store data records and information.

[0105] The data query and export module 406 includes a data query and export unit 406a and a data query and export database unit 406b. The data query and export unit 406a provides data query and export functions, allowing researchers to query and retrieve specific data as needed and export it to various formats, such as Excel and CSV, for further analysis and reporting. The data query and export database unit 406b stores data query and export information.

[0106] The data security and privacy protection module 407 includes a data security and privacy protection unit 407a and a data security and privacy protection database unit 407b. The data security and privacy protection unit 407a is used to establish a data security and privacy protection mechanism to ensure the confidentiality and compliance of patient data, allowing only authorized research team members to access and process patient data. The data security and privacy protection database unit 407b is used to store data security and privacy protection information.

[0107] Reference Figure 6 The report generation and analysis module 5 includes a report template and customization module 501, a data aggregation and statistical analysis module 502, a data visualization module 503, a data interaction and export module 504, a statistical report generation module 505, and a real-time data update module 506.

[0108] Specifically, the report template and customization module 501 includes a report template and customization unit 501a and a report template and customization database unit 501b. The report template and customization unit 501a provides multiple report templates for principal investigators to choose from and allows customization based on experimental needs. Principal investigators can select the content, format, and style of the report as needed, and add custom charts, tables, and text. The report template and customization database unit 501b stores report template and customization information.

[0109] The data aggregation and statistical analysis module 502 includes a data aggregation and statistical analysis unit 502a and a data aggregation and statistical analysis database unit 502b. The data aggregation and statistical analysis unit 502a provides data aggregation and statistical analysis functions, performing statistical descriptions of experimental data, calculating indicators, and generating summary reports. Principal investigators can use the system's built-in statistical analysis tools or integrate with external analysis software to perform common statistical analyses, chart creation, and other operations. The data aggregation and statistical analysis database unit 502b stores data aggregation and statistical analysis information.

[0110] The data visualization module 503 includes a data visualization unit 503a and a data visualization database unit 503b. The data visualization unit 503a allows principal researchers to present experimental results through data visualization, including generating charts, trend graphs, bar charts, pie charts, and other visual graphics to intuitively display the distribution, trends, and relationships of the data. The data visualization database unit 503b is used to store data visualization information.

[0111] The data interaction and export module 504 includes a data interaction and export unit 504a and a data interaction and export database unit 504b. The data interaction and export unit 504a provides data interaction and export functions, allowing the principal investigator to share data and reports with other research team members and export reports to various formats, such as PDF and Excel, for further analysis and sharing. The data interaction and export database unit 504b stores data interaction and export information.

[0112] The statistical report generation module 505 includes a statistical report generation unit 505a and a statistical report generation database unit 505b. The statistical report generation unit 505a generates statistical reports on the experimental results, including detailed data analysis results, statistical hypothesis testing, confidence intervals, effect sizes, and other information to support the interpretation and discussion of the research results. The statistical report generation database unit 505b stores the statistical report generation information.

[0113] The real-time data update module 506 includes a real-time data update unit 506a and a real-time data update database unit 506b. The real-time data update unit 506a is used by the principal investigator to update and regenerate reports at any time. When experimental data changes, the system can automatically update relevant reports and provide the latest analysis results. The real-time data update database unit 506b is used to store real-time data update information.

[0114] Reference Figure 7 The adverse event reporting module 6 includes an adverse event recording module 601, an adverse event classification and grading module 602, an adverse event assessment module 603, an adverse event report generation module 604, an adverse event notification and reporting module 605, and an adverse event tracking and handling module 606.

[0115] Specifically, the adverse event recording module 601 includes an adverse event recording unit 601a and an adverse event recording database unit 601b, which allows the principal investigator to record adverse events occurring in each patient, including information such as the event description, time of occurrence, duration, and severity. Predefined adverse event terms or user-defined terms can be used to describe the events. The adverse event recording database unit 601b is used to store adverse event recording information.

[0116] The adverse event classification and grading module 602 includes an adverse event classification and grading unit 602a and an adverse event classification and grading database unit 602b. The adverse event classification and grading unit 602a provides the function of classifying and grading adverse events. Principal investigators classify and grade events according to their nature, severity, and related factors, which helps distinguish between minor and serious adverse events and facilitates appropriate handling and reporting. The adverse event classification and grading database unit 602b stores adverse event classification and grading information.

[0117] The adverse event assessment module 603 includes an adverse event assessment unit 603a and an adverse event assessment database unit 603b. The adverse event assessment unit 603a contains adverse event assessment tools, which the principal investigator uses to assess events and determine their association with the trial intervention and possible causes. The adverse event assessment database unit 603b is used to store adverse event assessment information.

[0118] The adverse event report generation module 604 includes an adverse event report generation unit 604a and an adverse event report generation database unit 604b. The adverse event report generation unit 604a allows principal investigators to generate adverse event reports. These reports can include summaries, statistical information, and relevant data for all adverse events, as well as necessary analysis and interpretation. The reports are formatted according to regulatory requirements and research protocols. The adverse event report generation database unit 604b stores the adverse event report generation information.

[0119] The adverse event notification and reporting module 605 includes an adverse event notification and reporting unit 605a and an adverse event notification and reporting database unit 605b. The adverse event notification and reporting unit 605a provides functions for adverse event notification and reporting, allowing principal investigators to notify relevant research team members, regulatory agencies, and ethics committees of adverse events, automatically generating notifications and recording the sending and receiving of notifications. The adverse event notification and reporting database unit 605b stores adverse event notification and reporting information.

[0120] The adverse event tracking and handling module 606 includes an adverse event tracking and handling unit 606a and an adverse event tracking and handling database unit 606b. The adverse event tracking and handling unit 606a is used to track and record the handling process of each adverse event, including corrective actions taken, follow-up status, and results. This helps ensure that adverse events are handled and tracked in a timely manner and supports subsequent audits and reviews. The adverse event tracking and handling database unit 606b is used to store adverse event tracking and handling information.

[0121] Reference Figure 8The treatment management module 7 includes a treatment plan and protocol module 701, a treatment allocation and randomization module 702, a drug management and storage module 703, a treatment execution and monitoring module 704, an adverse event and side effect management module 705, and a treatment effect evaluation module 706.

[0122] Specifically, the treatment plan and protocol module 701 includes a treatment plan and protocol unit 701a and a treatment plan and protocol database unit 701b. The treatment plan and protocol unit 701a is used to allow the principal investigator to create and manage the treatment plan and protocol for the trial, including determining the specific content, dosage, frequency, and duration of the treatment intervention, as well as designating the treatment group and the control group. The treatment plan and protocol database unit 701b is used to store treatment plan and protocol information.

[0123] The treatment allocation and randomization module 702 includes a treatment allocation and randomization unit 702a and a treatment allocation and randomization database unit 702b. The treatment allocation and randomization unit 702a supports the treatment allocation and randomization functions to ensure that patients are randomly assigned to appropriate treatment groups, automatically assigning patients to treatment groups and / or providing randomization tools for manual allocation by the principal investigator. The treatment allocation and randomization database unit 702b stores treatment allocation and randomization information.

[0124] The drug management and storage module 703 includes a drug management and storage unit 703a and a drug management and storage database unit 703b. The drug management and storage unit 703a allows the principal investigator to manage drugs and therapeutic items involved in the trial, including drug procurement, storage, distribution, and tracking, and provides functions such as drug inventory management, expiration date reminders, and drug usage records. The drug management and storage database unit 703b is used to store drug management and storage information.

[0125] The treatment execution and monitoring module 704 includes a treatment execution and monitoring unit 704a and a treatment execution and monitoring database unit 704b. The treatment execution and monitoring unit 704a is used to record and monitor the patient's treatment status. The principal investigator can record information such as treatment implementation, treatment adherence, and dosage adjustments, and perform necessary monitoring and follow-up. The treatment execution and monitoring database unit 704b is used to store treatment execution and monitoring information.

[0126] The adverse event and side effect management module 705 includes an adverse event and side effect management unit 705a and an adverse event and side effect management database unit 705b. The adverse event and side effect management unit 705a allows the principal investigator to record and manage treatment-related adverse events and side effects. The principal investigator can track patient treatment responses and adverse events and take appropriate actions for handling and reporting. The adverse event and side effect management database unit 705b is used to store adverse event and side effect management information.

[0127] The treatment efficacy evaluation module 706 includes a treatment efficacy evaluation unit 706a and a treatment efficacy evaluation database unit 706b. The treatment efficacy evaluation unit 706a provides tools and indicators for evaluating treatment efficacy to help principal investigators assess the effectiveness and efficacy of treatment, including evaluation methods such as clinical measurements, laboratory results, and questionnaires. The treatment efficacy evaluation database unit 706b stores treatment efficacy evaluation information.

[0128] Reference Figure 9 The communication and collaboration module 8 includes an internal messaging and notification module 801, a task assignment and tracking module 802, a collaboration tool and document sharing module 803, a meeting and scheduling module 804, an external collaboration and communication module 805, and a real-time data sharing and tracking module 806.

[0129] Specifically, the internal messaging and notification module 801 includes an internal messaging and notification unit 801a and an internal messaging and notification database unit 801b. The internal messaging and notification unit 801a provides internal messaging and notification functionality, allowing principal investigators to directly communicate and share information with team members. This communication can be via text messages, email notifications, or internal instant messaging tools. The internal messaging and notification database unit 801b stores internal messaging and notification information.

[0130] The task allocation and tracking module 802 includes a task allocation and tracking unit 802a and a task allocation and tracking database unit 802b. The task allocation and tracking unit 802a allows the principal investigator to assign tasks to members of the experimental team and track the execution and progress of tasks. The principal investigator can specify task deadlines and receive reminders and notifications. The task allocation and tracking database unit 802b stores task allocation and tracking information.

[0131] The collaboration tools and document sharing module 803 includes a collaboration tools and document sharing unit 803a and a collaboration tools and document sharing database unit 803b. The collaboration tools and document sharing unit 803a integrates collaboration tools such as document sharing, online editing, and version control tools, enabling principal researchers and collaborators to jointly edit and share experiment-related documents, research protocols, and reports. The collaboration tools and document sharing database unit 803b is used to store collaboration tools and document sharing information.

[0132] The meeting and scheduling module 804 includes a meeting and scheduling unit 804a and a meeting and scheduling database unit 804b. The meeting and scheduling unit 804a supports meeting and scheduling functions, allowing principal researchers to create and manage meetings, invite participants, and share meeting agendas and related documents. The meeting and scheduling database unit 804b stores meeting and scheduling information.

[0133] The external collaboration and communication module 805 includes an external collaboration and communication unit 805a and an external collaboration and communication database unit 805b. The external collaboration and communication unit 805a supports collaboration and communication with external partners, regulatory agencies, ethics committees, and other relevant parties, including document exchange, notifications, and information sharing with external organizations. The external collaboration and communication database unit 805b stores external collaboration and communication information.

[0134] The real-time data sharing and tracking module 806 includes a real-time data sharing and tracking unit 806a and a real-time data sharing and tracking database unit 806b. The real-time data sharing and tracking unit 806a allows principal investigators to share experimental data and results in real time for discussion and feedback with team members. It ensures data security and integrity by tracking and recording the history and versions of data sharing. The real-time data sharing and tracking database unit 806b stores real-time data sharing and tracking information.

[0135] The above are all preferred embodiments of this application, and are not intended to limit the scope of protection of this application. Therefore, all equivalent changes made in accordance with the structure, shape and principle of this application should be covered within the scope of protection of this application.

Claims

1. A working system for principal investigators in clinical trials, characterized in that, include: The patient management terminal (1) includes a patient registration and screening module (101), a patient enrollment and exit management module (102), a follow-up plan and arrangement module (103), a patient status tracking module (104), a data collection and recording module (105), a data query and reporting module (106), and a patient safety and privacy protection module (107). The task management and reminder module (2) includes a task creation and assignment module (201), a task priority and deadline module (202), a task status tracking module (203), a reminder and notification module (204), a task history module (205), and a cross-team collaboration module (206). The visit planning and scheduling module (3) includes a visit planning module (301), a visit scheduling and reminder module (302), a visit status tracking module (303), a visit document management module (304), and a visit history module (305); The data collection and recording terminal (4) includes a data collection form design module (401), a data input and verification module (402), an automatic data collection module (403), a data audit and cleaning module (404), a data recording and storage module (405), a data query and export module (406), and a data security and privacy protection module (407). The report generation and analysis module (5) includes a report template and customization module (501), a data summary and statistical analysis module (502), a data visualization module (503), a data interaction and export module (504), a statistical report generation module (505), and a real-time data update module (506). The adverse event reporting terminal (6) includes an adverse event recording module (601), an adverse event classification and grading module (602), an adverse event assessment module (603), an adverse event report generation module (604), an adverse event notification and reporting module (605), and an adverse event tracking and handling module (606). The treatment management module (7) includes a treatment plan and protocol module (701), a treatment allocation and randomization module (702), a drug management and storage module (703), a treatment execution and monitoring module (704), an adverse event and side effect management module (705), and a treatment effect evaluation module (706). The communication and collaboration module (8) includes an internal messaging and notification module (801), a task assignment and tracking module (802), a collaboration tool and document sharing module (803), a meeting and scheduling module (804), an external collaboration and communication module (805), and a real-time data sharing and tracking module (806).

2. The operating system for a principal investigator in a clinical trial according to claim 1, characterized in that: The patient management terminal (1), task management and reminder terminal (2), visit planning and arrangement terminal (3), data collection and recording terminal (4), report generation and analysis terminal (5), adverse event reporting terminal (6), treatment management terminal (7), and communication and collaboration terminal (8) communicate with each other via a dedicated network.

3. The operating system for a principal investigator in a clinical trial according to claim 1, characterized in that: The patient registration and screening module (101) includes a patient registration and screening unit and a patient registration and screening database unit (101b). The patient registration and screening unit is used by the principal investigator to record the basic information of the patients. The principal investigator can screen and enroll patients according to preset screening criteria. The patient registration and screening database unit (101b) is used to store patient registration and screening information. The patient enrollment and exit management module (102) includes a patient enrollment and exit management unit (102a) and a patient enrollment and exit management database unit (102b). The patient enrollment and exit management unit (102a) is used to track the patient enrollment process and record the enrollment time, enrollment conditions and related documents. The patient enrollment and exit management database unit (102b) is used to store patient enrollment and exit management information. The follow-up planning and scheduling module (103) includes a follow-up planning and scheduling unit (103a) and a follow-up planning and scheduling database unit (103b). The follow-up planning and scheduling unit (103a) is used to develop and manage the patient's follow-up plan, with the principal investigator arranging the patient's follow-up time and content, and recording the follow-up results and necessary data. The follow-up planning and scheduling database unit (103b) is used to store follow-up planning and scheduling information. The patient status tracking module (104) includes a patient status tracking unit (104a) and a patient status tracking database unit (104b). The patient status tracking unit (104a) is used to track changes in the patient's status during the trial, including treatment progress, occurrence and management of adverse events, and dose adjustments. The patient status tracking database unit (104b) is used to store patient status tracking information. The data collection and recording module (105) includes a data collection and recording unit (105a) and a data collection and recording database unit (105b). The data collection and recording unit (105a) is used for collecting and recording patient data, whereby the principal investigator inputs or verifies the accuracy of the patient data, including diagnostic results, laboratory tests, drug use and dosage, and treatment response. The data collection and recording database unit (105b) is used to store data collection and recording information. The data query and reporting module (106) includes a data query and reporting unit (106a) and a data query and reporting database unit (106b). The data query and reporting unit (106a) is used for querying and reporting patient data, and generates reports and statistical information of patient data according to specific screening conditions and variables. The data query and reporting database unit (106b) is used to store data query and reporting information. The patient safety and privacy protection module (107) includes a patient safety and privacy protection unit (107a) and a patient safety and privacy protection database unit (107b). The patient safety and privacy protection unit (107a) is used to establish a security and privacy protection mechanism for patient data to ensure the confidentiality and compliance of patient information. The patient safety and privacy protection database unit (107b) is used to store patient safety and privacy protection information.

4. The operating system for a principal investigator in a clinical trial according to claim 1, characterized in that: The task creation and allocation module (201) includes a task creation and allocation unit (201a) and a task creation and allocation database unit (201b). The task creation and allocation unit (201a) is used by the principal investigator to create new tasks and allocate them to relevant research team members. The tasks can be various trial-related tasks such as those targeting specific patients, data collection, report generation, and meeting arrangements. The task creation and allocation database unit (201b) is used to store task creation and allocation information. The task priority and deadline module (202) includes a task priority and deadline unit (202a) and a task priority and deadline database unit (202b). The task priority and deadline unit (202a) is used by the principal investigator to set the priority and deadline of the task, and provides a task list and reminder function to help the principal investigator understand the current task status and follow up in a timely manner. The task priority and deadline database unit (202b) is used to store task priority and deadline information. The task status tracking module (203) includes a task status tracking unit (203a) and a task status tracking database unit (203b). The task status tracking unit (203a) is used by the principal researcher to track the status and progress of the task. The principal researcher can mark the task as completed, in progress, or pending, and record corresponding notes and updates. The task status tracking database unit (203b) is used to store task status tracking information. The reminder and notification module (204) includes a reminder and notification unit (204a) and a reminder and notification database unit (204b). The reminder and notification unit (204a) is used to send reminders and notifications to relevant research team members through internal messaging functions, emails, or mobile application push notifications. The reminder and notification database unit (204b) is used to store reminder and notification information. The task history module (205) includes a task history unit (205a) and a task history database unit (205b). The task history unit (205a) is used to record the history of the task, including the task creation time, assigned personnel, status changes and other information to help the main researchers trace the execution status and follow-up process of the task. The task history database unit (205b) is used to store the task history information. The cross-team collaboration module (206) includes a cross-team collaboration unit (206a) and a cross-team collaboration database unit (206b). The cross-team collaboration unit (206a) is used for the principal researcher to share tasks, discuss problems, and solve problems together with other research team members. The cross-team collaboration database unit (206b) is used to store cross-team collaboration information.

5. The operating system for a principal investigator in a clinical trial according to claim 1, characterized in that: The visit planning module (301) includes a visit planning unit (301a) and a visit planning database unit (301b). The visit planning unit (301a) is used to develop a visit plan, determine the time points for patient visits and follow-ups, and develop the visit plan according to the specific requirements and procedures of the trial, and adjust it according to the research agreement and regulatory requirements. The visit planning database unit (301b) is used to store visit plan development information. The visit scheduling and reminder module (302) includes a visit scheduling and reminder unit (302a) and a visit scheduling and reminder database unit (302b). The visit scheduling and reminder unit (302a) is used to allow the principal investigator to send the planned visit to the patient and set reminder notifications to ensure that the patient and the research team are aware of the time and place of the visit in a timely manner, which is achieved through the system's internal messaging function, email, or mobile application push. The visit scheduling and reminder database unit (302b) is used to store visit scheduling and reminder information. The visit status tracking module (303) includes a visit status tracking unit (303a) and a visit status tracking database unit (303b). The visit status tracking unit (303a) is used to track and record the status and progress of each patient visit. The principal investigator can mark the visit as completed, in progress, or pending, and record the relevant visit results and data. The visit status tracking database unit (303b) is used to store visit status tracking information. The visit document management module (304) includes a visit document management unit (304a) and a visit document management database unit (304b). The visit document management unit (304a) is used to allow principal researchers and research teams to upload, manage and share visit-related documents and materials. The visit document management database unit (304b) is used to store visit document management information. The visit history module (305) includes a visit history unit (305a) and a visit history database unit (305b). The visit history unit (305a) is used to record the visit history of each patient, including visit time, visit purpose, and visit results. The visit history database unit (305b) is used to store visit history information.

6. The operating system for a principal investigator in a clinical trial according to claim 1, characterized in that: The data collection form design module (401) includes a data collection form design unit (401a) and a data collection form design database unit (401b). The data collection form design unit (401a) is used by the principal investigator to design and create data collection forms, wherein the forms can be defined according to the specific needs of the experiment and the research protocol, and contain various data fields and variables that need to be collected. The data collection form design database unit (401b) is used to store data collection form design information. The data input and verification module (402) includes a data input and verification unit (402a) and a data input and verification database unit (402b). The data input and verification unit (402a) provides a data input interface, where the principal investigator can manually input patient data and verify the data to ensure that the input data conforms to the prescribed format and range, and provides error prompts or warning messages. The data input and verification database unit (402b) stores data input and verification information. The automatic data collection module (403) includes an automatic data collection unit (403a) and an automatic data collection database unit (403b). The automatic data collection unit (403a) is used to integrate with other test-related systems or equipment to automatically collect test data. The automatic data collection database unit (403b) is used to store automatic data collection information. The data review and cleaning module (404) includes a data review and cleaning unit (404a) and a data review and cleaning database unit (404b). The data review and cleaning unit (404a) is used to allow the principal investigator to review and clean the data and perform necessary corrections and cleaning operations. The data review and cleaning database unit (404b) is used to store data review and cleaning information. The data recording and storage module (405) includes a data recording and storage unit (405a) and a data recording and storage database unit (405b). The data recording and storage unit (405a) is used to automatically record and store collected data. The data records include timestamps, data sources, and operator information to ensure the traceability and reliability of the data. The data recording and storage database unit (405b) is used to store data records and storage information. The data query and export module (406) includes a data query and export unit (406a) and a data query and export database unit (406b). The data query and export unit (406a) is used to provide data query and export functions, allowing researchers to query and retrieve specific data as needed and export it in various formats for further analysis and reporting. The data query and export database unit (406b) is used to store data query and export information. The data security and privacy protection module (407) includes a data security and privacy protection unit (407a) and a data security and privacy protection database unit (407b). The data security and privacy protection unit (407a) is used to establish a data security and privacy protection mechanism to ensure the confidentiality and compliance of patient data, and only authorized research team members can access and process patient data. The data security and privacy protection database unit (407b) is used to store data security and privacy protection information.

7. The operating system for a principal investigator in a clinical trial according to claim 1, characterized in that: The report template and customization module (501) includes a report template and customization unit (501a) and a report template and customization database unit (501b). The report template and customization unit (501a) provides a variety of report templates for principal investigators to choose from and allows customization according to experimental needs. Principal investigators can select the content, format, and style of the report as needed, and add custom charts, tables, and text. The report template and customization database unit (501b) stores report template and customization information. The data aggregation and statistical analysis module (502) includes a data aggregation and statistical analysis unit (502a) and a data aggregation and statistical analysis database unit (502b). The data aggregation and statistical analysis unit (502a) is used to provide data aggregation and statistical analysis functions, perform statistical description of experimental data, calculate indicators, and generate summary reports. The data aggregation and statistical analysis database unit (502b) is used to store data aggregation and statistical analysis information. The data visualization module (503) includes a data visualization unit (503a) and a data visualization database unit (503b). The data visualization unit (503a) is used to allow the principal researcher to present the experimental results through data visualization. The data visualization database unit (503b) is used to store data visualization information. The data interaction and export module (504) includes a data interaction and export unit (504a) and a data interaction and export database unit (504b). The data interaction and export unit (504a) is used to provide data interaction and export functions, allowing the principal investigator to share data and reports with other research team members and export reports in multiple formats. The data interaction and export database unit (504b) is used to store data interaction and export information. The statistical report generation module (505) includes a statistical report generation unit (505a) and a statistical report generation database unit (505b). The statistical report generation unit (505a) is used to generate statistical reports on experimental results, wherein the statistical report includes detailed results of data analysis, statistical hypothesis testing, confidence intervals, effect sizes, and other information to support the interpretation and discussion of research results. The statistical report generation database unit (505b) is used to store statistical report generation information. The real-time data update module (506) includes a real-time data update unit (506a) and a real-time data update database unit (506b). The real-time data update unit (506a) is used by the principal investigator to update and regenerate reports at any time. When experimental data changes, the system can automatically update the relevant reports and provide the latest analysis results. The real-time data update database unit (506b) is used to store real-time data update information.

8. The operating system for a principal investigator in a clinical trial according to claim 1, characterized in that: The adverse event recording module (601) includes an adverse event recording unit (601a) and an adverse event recording database unit (601b), which allows the principal investigator to record adverse events occurring in each patient; the adverse event recording database unit (601b) is used to store adverse event recording information. The adverse event classification and grading module (602) includes an adverse event classification and grading unit (602a) and an adverse event classification and grading database unit (602b). The adverse event classification and grading unit (602a) is used to provide the function of classifying and grading adverse events, mainly by researchers classifying and grading events according to their nature, severity, and related factors. The adverse event classification and grading database unit (602b) is used to store adverse event classification and grading information. The adverse event assessment module (603) includes an adverse event assessment unit (603a) and an adverse event assessment database unit (603b). The adverse event assessment unit (603a) contains an adverse event assessment tool, which the principal investigator uses to assess the event and determine its association with the trial intervention and possible causes. The adverse event assessment database unit (603b) is used to store adverse event assessment information. The adverse event report generation module (604) includes an adverse event report generation unit (604a) and an adverse event report generation database unit (604b). The adverse event report generation unit (604a) allows principal investigators to generate adverse event reports. The reports may include summaries, statistical information, and relevant data of all adverse events, as well as necessary analysis and interpretation. The reports are formatted in accordance with regulatory requirements and research protocols. The adverse event report generation database unit (604b) stores adverse event report generation information. The adverse event notification and reporting module (605) includes an adverse event notification and reporting unit (605a) and an adverse event notification and reporting database unit (605b). The adverse event notification and reporting unit (605a) is used to provide the function of adverse event notification and reporting, allowing the principal investigator to notify relevant research team members, regulatory agencies, and ethics committees of adverse events. The adverse event notification and reporting database unit (605b) is used to store adverse event notification and reporting information. The adverse event tracking and handling module (606) includes an adverse event tracking and handling unit (606a) and an adverse event tracking and handling database unit (606b). The adverse event tracking and handling unit (606a) is used to track and record the handling process of each adverse event, including corrective measures taken, follow-up status, and results. The adverse event tracking and handling database unit (606b) is used to store adverse event tracking and handling information.

9. The operating system for a principal investigator in a clinical trial according to claim 1, characterized in that: The treatment plan and protocol module (701) includes a treatment plan and protocol unit (701a) and a treatment plan and protocol database unit (701b). The treatment plan and protocol unit (701a) is used to allow the principal investigator to create and manage the treatment plan and protocol for the trial. The treatment plan and protocol database unit (701b) is used to store treatment plan and protocol information. The treatment allocation and randomization module (702) includes a treatment allocation and randomization unit (702a) and a treatment allocation and randomization database unit (702b). The treatment allocation and randomization unit (702a) is used to support the treatment allocation and randomization function to ensure that patients are randomly assigned to appropriate treatment groups, automatically allocate patients to treatment groups, and / or provide randomization tools for the principal investigator to perform manual allocation. The treatment allocation and randomization database unit (702b) is used to store treatment allocation and randomization information. The drug management and storage module (703) includes a drug management and storage unit (703a) and a drug management and storage database unit (703b). The drug management and storage unit (703a) is used to allow the principal investigator to manage drugs and therapeutic items involved in the trial; the drug management and storage database unit (703b) is used to store drug management and storage information. The treatment execution and monitoring module (704) includes a treatment execution and monitoring unit (704a) and a treatment execution and monitoring database unit (704b). The treatment execution and monitoring unit (704a) is used to record and monitor the patient's treatment status. The principal investigator can record information such as treatment implementation, treatment compliance, and dosage adjustments, and perform necessary monitoring and tracking. The treatment execution and monitoring database unit (704b) is used to store treatment execution and monitoring information. The adverse event and side effect management module (705) includes an adverse event and side effect management unit (705a) and an adverse event and side effect management database unit (705b). The adverse event and side effect management unit (705a) allows the principal investigator to record and manage treatment-related adverse events and side effects, enabling the principal investigator to track patient treatment responses and adverse events and take appropriate measures for handling and reporting. The adverse event and side effect management database unit (705b) stores adverse event and side effect management information. The treatment effect evaluation module (706) includes a treatment effect evaluation unit (706a) and a treatment effect evaluation database unit (706b). The treatment effect evaluation unit (706a) is used to provide treatment effect evaluation tools and indicators to help the principal investigator evaluate the effect and efficacy of the treatment. The treatment effect evaluation database unit (706b) is used to store treatment effect evaluation information.

10. The operating system for a principal investigator in a clinical trial according to claim 1, characterized in that: The internal message and notification module (801) includes an internal message and notification unit (801a) and an internal message and notification database unit (801b). The internal message and notification unit (801a) is used to provide internal message and notification functions, allowing the principal researcher to communicate and share information directly with members of the experimental team. The internal message and notification database unit (801b) is used to store internal message and notification information. The task allocation and tracking module (802) includes a task allocation and tracking unit (802a) and a task allocation and tracking database unit (802b). The task allocation and tracking unit (802a) is used to allow the principal investigator to allocate tasks to members of the experimental team and track the execution status and progress of the tasks. The task allocation and tracking database unit (802b) is used to store task allocation and tracking information. The collaboration tools and document sharing module (803) includes a collaboration tools and document sharing unit (803a) and a collaboration tools and document sharing database unit (803b). The collaboration tools and document sharing unit (803a) integrates collaboration tools to enable principal researchers and collaborators to jointly edit and share experiment-related documents, research plans, and reports. The collaboration tools and document sharing database unit (803b) is used to store collaboration tools and document sharing information. The meeting and scheduling module (804) includes a meeting and scheduling unit (804a) and a meeting and scheduling database unit (804b). The meeting and scheduling unit (804a) is used to support meeting and scheduling functions, allowing principal researchers to create and manage meetings, invite participants, and share meeting agendas and related documents. The meeting and scheduling database unit (804b) is used to store meeting and scheduling information. The external collaboration and communication module (805) includes an external collaboration and communication unit (805a) and an external collaboration and communication database unit (805b). The external collaboration and communication unit (805a) is used to support collaboration and communication with external partners, regulatory agencies, ethics committees, and other relevant parties. The external collaboration and communication database unit (805b) is used to store external collaboration and communication information. The real-time data sharing and tracking module (806) includes a real-time data sharing and tracking unit (806a) and a real-time data sharing and tracking database unit (806b). The real-time data sharing and tracking unit (806a) is used to allow the principal investigator to share experimental data and results in real time for discussion and feedback with team members. The real-time data sharing and tracking database unit (806b) is used to store real-time data sharing and tracking information.

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